FDA approved Ryoncil (remestemcel-L-rknd), an allogeneic bone marrow-derived mesenchymal stromal cell therapy, for steroid-refractory acute graft versus host disease in pediatric patients two months of age and older. Ryoncil is the first FDA-approved MSC therapy.
FDA approved Opdivo (nivolumab) and Opdivo Qvantig (hyaluronidase-nvhy) for subcutaneous injection across approved adult, solid tumor Opdivo indications as monotherapy, monotherapy maintenance following completion of Opdivo plus Yervoy (ipilimumab) combination therapy, or in combination with chemotherapy or cabozantinib.
FDA granted accelerated approval to encorafenib (Braftovi) with cetuximab and mFOLFOX6 for patients with metastatic colorectal cancer (mCRC) with a BRAF V600E mutation, as detected by an FDA-approved test.
The European Commission has approved Opdivo (nivolumab) plus Yervoy (ipilimumab) for the first-line treatment of adult patients with microsatellite instability-high or mismatch repair deficient unresectable or metastatic colorectal cancer.
FDA cleared an investigational new drug application for a phase I/II clinical trial of REC-4539, a brain penetrant LSD1 inhibitor. Initial clinical investigation will focus on small cell lung cancer while also exploring several other solid tumor indications.
FDA approved durvalumab (Imfinzi, AstraZeneca) for adults with limited-stage small cell lung cancer whose disease has not progressed following concurrent platinum-based chemotherapy and radiation therapy.
The University of Texas MD Anderson Cancer Center and AmMax Bio, Inc. announced a worldwide exclusive license agreement and clinical trial agreement to develop and advance AmMax’s AMB-066 monoclonal antibody therapy as a first-in-class treatment option for patients with colorectal cancer and minimal residual disease as well as those with MRD in other solid tumors.
PolyPid Ltd. announced a new research and development collaboration with ImmunoGenesis Inc. The collaboration focuses on the development of novel formulations utilizing PolyPid’s experience with its proprietary PLEX Technology and ImmunoGenesis’ potent STimulator of INterferon Genes agonist drug candidate to potentially enhance treatment for solid tumors.
Dewpoint Therapeutics and ConcertAI announced the first phase of their Translational Oncology partnership, aligned around Dewpoint’s latest drug candidate, DPTX3186.
FDA has granted accelerated approval to zenocutuzumab-zbco (Bizengri) for adults
